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Life-Sciences eQMS 18 items

Aseptic Processing & Sterile Manufacturing Checklist

Verifies environmental, personnel, and process controls for aseptic manufacturing of sterile drug products. Use for cleanroom readiness, batch review, and self-inspection.

FDA Aseptic Processing Guidance (2004)EU GMP Annex 121 CFR 211USP <797>

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Facility and Cleanroom Classification

  • Are cleanroom areas classified (ISO 5 / Grade A critical zone within Grade B) and qualified? *
  • Is unidirectional airflow (HEPA) maintained over the critical aseptic work zone? *
  • Are room pressure differentials monitored and within limits? *
  • Record the current Grade A/B differential pressure reading (Pa).

Personnel and Gowning

  • Are aseptic operators qualified through gowning qualification and periodic requalification? *
  • Is aseptic technique training documented for all personnel entering the critical area? *
  • Is personnel monitoring (gloves/gown) performed and trended? *

Environmental Monitoring

  • Is viable and non-viable particulate monitoring performed at defined locations and frequencies? *
  • Are alert and action limits established, trended, and investigated on excursion? *
  • Is the critical zone monitored during each production shift/operation? *

Sterilization and Depyrogenation

  • Are sterilization processes (steam, filtration, dry heat) validated for the load configurations used? *
  • Is sterilizing-grade filtration integrity tested pre- and post-use? *
  • Is depyrogenation of containers/closures validated to achieve the required endotoxin reduction? *

Media Fill / Process Simulation

  • Are aseptic process simulations (media fills) performed at the required frequency per line and operator? *
  • Record the number of units filled in the most recent media fill.
  • Were media fill results within the acceptance criteria (target zero positives)? *

Contamination Control Strategy

  • Is a documented contamination control strategy (CCS) in place and current? *
  • Are interventions during aseptic processing defined, minimized, and documented? *

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